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. 2016 Feb 4;11:193–205. doi: 10.2147/COPD.S95055

Table 5.

Peak0–3 FEV1 response at study Day 1 and Day 43 and trough FEV1 responses after 6 weeks of treatment, showing the differences between treatments (full analysis set)

Treatment comparison
Tiotropium + olodaterol 5/5 µg versus
Tiotropium + olodaterol 2.5/5 µg versus
Salmeterol + fluticasone propionate 50/500 µg Salmeterol + fluticasone propionate 50/250 µg Salmeterol + fluticasone propionate 50/500 µg Salmeterol + fluticasone propionate 50/250 µg
Peak0–3 FEV1, mL, Day 1
 Adjusted mean (SE) 80 (9) 95 (9) 61 (9) 76 (9)
 95% CI 62, 97 77, 112 44, 79 59, 94
P-value <0.0001 <0.0001 <0.0001 <0.0001
Peak0–3 FEV1, mL, Day 43
 Adjusted mean (SE) 147 (12) 142 (12) 116 (12) 111 (12)
 95% CI 123, 171 118, 166 92, 140 87, 135
P-value <0.0001 <0.0001 <0.0001 <0.0001
Trough FEV1, mL
 Adjusted mean (SE) 58 (12) 47 (12) 54 (12) 42 (12)
 95% CI 34, 82 22, 71 29, 78 18, 67
P-value <0.0001 0.0002 <0.0001 0.0007

Notes: The adjusted mean (SE) was obtained from fitting a mixed-effects repeated-measures model including the following: fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation; and Kenward–Roger approximation of denominator degrees of freedom.

Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; peak0–3 FEV1, peak forced expiratory volume in 1 second from 0 hour to 3 hours; SE, standard error.